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临床试验/NCT03972163
NCT03972163已完成不适用

Standardized PatiEnt-CenTered medicatiOn Review (SPECTORx) in Home Hospice

University of Massachusetts, Worcester2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2020年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
23
试验地点
2
主要终点
Intervention Training Completion by Hospice Staff

研究概览

简要总结

This is a pilot cluster randomized trial that tests the effect of a novel intervention that trains hospice staff to 1. regularly review, simplify, and align patients' prescribed medications with their goals of care as their illness progresses, and 2. support family caregivers with education that empowers them to understand each medication's use, develop skills for safe administration, and 3. understand when stopping medications may be beneficial.

详细描述

A tremendous challenge in home hospice care is ensuring that medication prescribing is appropriately aligned to patients' goals of care and that medications are appropriately managed by family caregivers. Therefore, the Investigators propose a novel intervention that trains hospice staff to 1. regularly review, simplify, and align patients' prescribed medications with their goals of care as their illness progresses, and 2. support family caregivers with education that empowers them to understand each medication's use, develop skills for safe administration, and understand when stopping medications may be beneficial. This program is called Standardized PatiEnt-CenTered medicatiOn Review (SPECTORx) in Home Hospice, and is based on a combination of 3 existing, complementary, educational programs that, together, train hospice staff to create a comprehensive, patient-centered, medication management care plan. The program also creates an online learning community that promotes ongoing education and practice change for hospice clinicians. This pilot study aims to demonstrate the feasibility of conducting a clinical trial to evaluate the efficacy of SPECTORx. The long-term objective is to test the hypothesis that SPECTORx reduces inappropriate medication prescribing and improves family caregiver reported quality of care. However, to accomplish this, the Investigators must first address challenging questions regarding the design, feasibility, and execution of trials in home hospice. The Investigators will accomplish this using a stakeholder engagement process to refine the SPECTORx intervention and trial protocol. The Investigators will then conduct a pilot cluster randomized trial and compare outcomes within and across 2 large, multi-office, hospice agencies from Utah and Massachusetts. Within each hospice agency, the Investigators will randomize 1 office to intervention and 1 office to attention control. Target enrollment is n=60 family caregiver-patient dyads of patients aged ≥65 years with advanced, life-limiting illness. Primary outcomes are acceptability and feasibility of the SPECTORx intervention by hospice stakeholders, and acceptability, burden and completion of family caregiver assessments (Family Caregiver Medication Administration Hassle Scale at baseline, 2 weeks, 4 weeks, 12 weeks, and quarterly). The overarching goal of this research is to align patient's prescribed medications with their goals of care at each stage of their advanced illness and to support family caregivers' medication management challenges. Ultimately, the Investigators want to improve the quality of medication prescribing, reduce treatment complexity and medication-related harm, and improve family caregiver outcomes for the almost 600,000 elderly Americans who receive home hospice services annually.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

Randomization to the educational intervention targeting hospice clinicians is at the level of the hospice. Within each of the 2 hospice agencies, The Investigators will randomize 1 office to intervention and 1 to control status. Outcomes assessment is at the level of the patient and family caregiver who will be masked to randomization status.

入排标准

年龄范围
65 Years 至 110 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient - Newly admitted home hospice enrollees, aged ≥65 years old with:
  • advanced life-limiting illness;
  • an estimated life expectancy of >1 month;
  • recent functional status decline (defined as change in Karnofsky Performance Status [KPS] to < 80% in prior 3 months);
  • polypharmacy (defined as ≥ 5 regularly scheduled medications [excluding antimicrobials]);
  • cognitive ability to provide informed consent based on a Short Portable Mental Status Questionnaire (SPMSQ) score ≥6 OR, with a legally authorized representative who is willing and able to provide proxy consent.
  • Family ("any relative, partner, friend or neighbor who has a significant personal relationship with, and provides a broad range of assistance) Caregiver -
  • self-identification as "usually" or "always" providing care to the eligible patient;
  • English-speaking;
  • telephone access; and
  • cognitive ability to participate.

排除标准

  • Imminent death;
  • pain crisis;
  • no family caregiver or health care proxy
  • Family Caregiver:
  • no telephone access;
  • cognitive impairment.

结局指标

主要结局

Intervention Training Completion by Hospice Staff

时间窗: Baseline

Number of Completed Intervention Trainings

Patient and Family Caregiver Eligibility Screens

时间窗: 2 weeks prior to enrollment

Number of Eligible Dyad Participants (i.e. participant = 1 dyad) screened for potential eligibility to inform subsequent eligibility criteria to obtain a sufficient study population.

Completion of Primary Patient Outcome--Retention

时间窗: Baseline

Number of Dyads who completed the Medication Regimen Complexity Score at Baseline

Patient and Family Caregiver Enrollment

时间窗: Baseline

Number of Patients and Family Caregivers who enrolled

次要结局

  • Family Caregiver Medication Administration Hassle Scale(Baseline, 2, 4, 6, 8 12, 16, 20, 24 weeks(or death))
  • Medication Regimen Complexity Index(Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks(or death))
  • Potential Adverse Event(Week 2, 4, 6, 8, 12, 16, 20, 24)

研究者

发起方
University of Massachusetts, Worcester
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Tjia

Professor

University of Massachusetts, Worcester

研究点 (2)

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